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Download Directive in PDF More Circulars / Directives
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Download Directive in PDF More Circulars / Directives
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Download Directive in PDF More Circulars / Directives
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Download Directive in PDF More Circulars / Directives
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Download Directive in PDF
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Download Directive in PDF
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Download Directive in PDF
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Document Name Download Updated Dokumen Panduan Keperluan Direktif Bilangan 2 Tahun 2014 dan Bilangan 2 Tahun 2015 DOWNLOAD July-2018
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Document Name Download Updated Garis Panduan Pemeriksaan Amalan Perkilangan Baik (APB) bagi Premis Pengilang Produk Veterinar Berdaftar DOWNLOAD July-2018
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National Pharmaceutical Regulatory Division (NPRA) has implemented Cold Chain Inspection (CCI) to be carried out on each lot of registered vaccine or plasma product that is imported to Malaysia since…
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Document Name Updated Guidelines for Control of Cosmetic Products in Malaysia Aug-22 Annex I, Part 1: Illustrative List Of Cosmetic Products By Categories Aug-22 Annex I, Part 2: Non-Permissible…
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Cosmetic Notification Holder (CNH) The CNH refers to a company who is responsible for placing the cosmetic product in the market. The CNH must be a locally incorporated company or legal entity in the…
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5.1 Rejection of Notification Submission5.2 Cancellation of Notification Note5.3 Product Recall5.4 Punitive Action/Penalty 5.1 Rejection of Notification Submission All cosmetic notification…
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4.1 Post Market Surveillance Activities4.2 Product Sampling Requirements4.3 Product Complaint4.4 Reporting Of Adverse Event4.5 Notification of Product Quality Issue (PMAS) 4.1 Post Market…
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CNH must ensure compliance to the following requirements prior to notification submission. 3.1 Product Particulars3.2 Safety Requirements3.3 Cosmetic Ingredients3.4 Labelling Requirements3.5 Cosmetic…
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2. COSMETIC NOTIFICATION 2.1 Who Shall Submit for Cosmetic Notification 2.2 Responsibility of the CNH 2.3 Submission of Notification 2.4 Language 2.5 Privacy Markings 2.6 Fee 2.7 Notification…
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QUEST3+ System is only compatible with Google Chrome & Mozilla Firefox Version 45 to version 51. Please uninstall Firefox version 52 and above and reinstall with following firefox version : No…
No. Document Name Download 1 USER MANUAL QUEST 3+ Digital Certificate (USB Token) - Using Mozilla Firefox : Installation, Configuration & Troubleshooting DOWNLOAD 2 USER MANUAL QUEST 3+ Digital…
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21.0 Post-Marketing Activities 21.1 Pharmacovigilance 21.1.1 Reporting Adverse Drug Reaction (ADR) and Adverse Events Following Immunisation (AEFI) and Safety Updates 21.2 Post-Market Surveillance…
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Document Name Download Updated Appendix 6 : Guideline On Regulatory Control Of Active Pharmaceutical Ingredients (APIs) DOWNLOAD July-2018
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This guideline consists of general and specific requirements for the POA submission. The general requirements are referred for POA content whilst details of specific requirements are illustrated…
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Document Name Download Updated Glossary DOWNLOAD July-2018
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Label (Mock-up) for Diluent Please provide label (mockup) for diluent. Section Attachment/Information D1 Label (Mock-up) for Immediate Container Please refer: Appendix 9: 9.1.1 LABEL (MOCK-UP) FOR…
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Document Name Download Updated Appendix 13 : Supporting Documents Required For Change Of Manufacturing Site (Cos) Application DOWNLOAD July-2018
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